29.12.2006   

EN

Official Journal of the European Union

L 384/75

(1)

Groups of materials and articles listed in Annex I to Regulation (EC) No 1935/2004 and combinations of those materials and articles or recycled materials and articles used in those materials and articles should be manufactured in compliance with general and detailed rules on good manufacturing practice (GMP).

(2)

Some sectors of industry have established GMP guidelines, while others have not. Consequently, it appears necessary to ensure uniformity among Member States as regards GMP for materials and articles intended to come into contact with food.

(3)

In order to ensure such conformity, it is appropriate to lay down certain obligations on business operators.

(4)

All business operators should operate an effective quality management of their manufacturing operations which should be adapted to their position in the supply chain.

(5)

The rules should apply to materials and articles intended to be brought into contact with food, or already in contact with food and were intended for this purpose, or those which can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use.

(6)

The rules on GMP should be applied proportionately to avoid undue burdens for small businesses.

(7)

Detailed rules should now be set for processes involving printing inks and should be established for other processes as necessary. For printing inks applied to the non-food contact side of a material or article GMP should in particular ensure that substances are not transferred into food by set-off or transfer through the substrate.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)

‘good manufacturing practice (GMP)’ means those aspects of quality assurance which ensure that materials and articles are consistently produced and controlled to ensure conformity with the rules applicable to them and with the quality standards appropriate to their intended use by not endangering human health or causing an unacceptable change in the composition of the food or causing a deterioration in the organoleptic characteristics thereof;

(b)

‘quality assurance system’ means the total sum of the organised and documented arrangements made with the purpose of ensuring that materials and articles are of the quality required to ensure conformity with the rules applicable to them and the quality standards necessary for their intended use;

(c)

‘quality control system’ means the systematic application of measures established within the quality assurance system that ensure compliance of starting materials and intermediate and finished materials and articles with the specification determined in the quality assurance system;

(d)

‘non-food-contact side’ means the surface of the material or article that is not directly in contact with food;

(e)

‘food-contact side’ means the surface of a material or article that is directly in contact with the food.

(a)

the general rules on GMP as provided for in Article 5, 6, and 7,

(b)

the detailed rules on GMP as set out in the Annex.

(a)

take account of the adequacy of personnel, their knowledge and skills, and the organisation of the premises and equipment such as is necessary to ensure that finished materials and articles comply with the rules applicable to them;

(b)

be applied taking into account the size of the business run by the operator, so as not to be an excessive burden on the business.